Treatment of Chronic Low Back and Lower Extremity Pain - Full Text View

Purpose

To demonstrate clinically significant improvements in patients undergoing lumbar interlaminar epidurals. Improvement will be assessed in relation to the clinical outcome measures of pain and function.
To evaluate and compare the adverse event profile in all patients.

Condition	Intervention
Low Back Pain	Procedure: Lumbar Interlaminar Epidural Procedure: Lumbar Interlaminar Epidural injection

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Randomized, Prospective, Double-Blind Controlled Evaluation of the Effectiveness of Lumbar Interlaminar Epidural Injections in Lumbar Disc Herniation, and Discogenic Pain

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Hernia

U.S. FDA Resources

Further study details as provided by Pain Management Center of Paducah:

Primary Outcome Measures:

To demonstrate clinically significant improvement or lack thereof with the lumbar interlaminar epidural patients with or without steroids. [ Time Frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids. [ Time Frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months. ] [ Designated as safety issue: No ]
To evaluate and compare the adverse event profile in all patients. [ Time Frame: Patients will return for follow-up visits at 3, 6, 12, 18, and 24 months post-treatment. The recruitment period is estimated as 24 months with an anticipated study duration of 48 months. ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	February 2008
Estimated Study Completion Date:	May 2012
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group I Lumbar interlaminar epidural injection with local anesthetic only	Procedure: Lumbar Interlaminar Epidural Lumbar interlaminar epidural injections under fluoroscopy Epidural tray and needle Drugs: 0.5% Xylocaine and non-particulate Celestone Procedure: Lumbar Interlaminar Epidural injection Lumbar interlaminar epidural injections under fluoroscopy Epidural tray and needle Drugs: 0.5% Xylocaine and non-particulate Celestone
Group II Lumbar Interlaminar Epidural Injection with local anesthetic wiht 6 mg of non-particulate Celestone	Procedure: Lumbar Interlaminar Epidural Lumbar interlaminar epidural injections under fluoroscopy Epidural tray and needle Drugs: 0.5% Xylocaine and non-particulate Celestone Procedure: Lumbar Interlaminar Epidural injection Lumbar interlaminar epidural injections under fluoroscopy Epidural tray and needle Drugs: 0.5% Xylocaine and non-particulate Celestone

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects of at least 18 years of age
Subjects with a history of chronic, function-limiting chronic low back pain of at least 6 months in duration
Subjects who are able to give voluntary, written informed consent to participate in this investigation
Subjects who, in the opinion of the PI, are able to understand this investigation, co-operate with the investigational procedures, and are willing to return to the center for all the required post-operative follow-ups
Subjects have not had recent surgical procedures within the last 3 months.

Exclusion Criteria:

Cauda Equina symptoms and/or compressive radiculopathy
Narcotic use of no greater than hydrocodone 100 mg/day, methadone of 60 mg, or morphine 180 mg, or dose equivalent
Uncontrolled major depression or uncontrolled psychiatric disorders
Uncontrolled or acute medical illnesses including coagulopathy, renal insufficiency, chronic liver dysfunction, progressive neurological deficit, urinary sphincter dysfunction, infection, increased intracranial pressure, pseudotumor cerebri, intracranial tumors, unstable angina, and severe chronic obstructive pulmonary disease.
Chronic severe conditions that could interfere with the interpretations of the outcome assessments for pain and bodily function
Women who are pregnant or lactating
Subjects who have participated in a clinical study with an investigational product within 30 days of enrollment
Patients with multiple complaints involving concomitant hip osteoarthritis, due to the overlap of pain complaints
Inability to achieve appropriate positioning and inability to understand informed consent and protocol
History of adverse reaction to local anesthetic or anti-inflammatory drugs and history of gastrointestinal bleeding or ulcers
Previous surgery.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681447

Locations

United States, Kentucky
Ambulatory Surgery Center
Paducah, Kentucky, United States, 42001

Sponsors and Collaborators

Pain Management Center of Paducah

Investigators

Principal Investigator:

Laxmaiah Manchikanti, MD

Ambulatory Surgery Center, Paducah

More Information

No publications provided by Pain Management Center of Paducah

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Manchikanti L, Cash KA, McManus CD, Damron KS, Pampati V, Falco FJ. Lumbar interlaminar epidural injections in central spinal stenosis: preliminary results of a randomized, double-blind, active control trial. Pain Physician. 2012 Jan-Feb;15(1):51-63.

Manchikanti L, Cash KA, McManus CD, Pampati V, Benyamin RM. Preliminary results of a randomized, double-blind, controlled trial of fluoroscopic lumbar interlaminar epidural injections in managing chronic lumbar discogenic pain without disc herniation or radiculitis. Pain Physician. 2010 Jul;13(4):E279-92.

Manchikanti L, Singh V, Falco FJ, Cash KA, Pampati V. Evaluation of the effectiveness of lumbar interlaminar epidural injections in managing chronic pain of lumbar disc herniation or radiculitis: a randomized, double-blind, controlled trial. Pain Physician. 2010 Jul;13(4):343-55.

Responsible Party:	Laxmaiah Manchikanti, MD, Medical Director, Pain Management Center of Paducah
ClinicalTrials.gov Identifier:	NCT00681447 History of Changes
Other Study ID Numbers:	protocol 15
Study First Received:	March 14, 2008
Last Updated:	March 21, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Pain Management Center of Paducah:

lumbar disc herniation
discogenic pain
lumbar interlaminar epidural
injections

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain

Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013